两种下颌前移装置治疗阻塞性睡眠呼吸暂停的临床研究：一项初步随机对照试验

Clinical study of two mandibular advancement devices in the treatment of Obstructive Sleep Apnea: a pilot randomized controlled trial.

作者信息

Yu Liang, Mao Ruohui, Zhang Chaoyuan, Zhao Jing, Lin Nengjie, Sun Zhe, Zheng Yuanna

机构信息

School/Hospital of Stomatology, Zhejiang Chinese Medical University, Hangzhou, China.

Department of Stomatology, Hangzhou Hospital of Traditional Chinese Medicine, Hangzhou, China.

出版信息

BMC Oral Health. 2024 Dec 18;24(1):1492. doi: 10.1186/s12903-024-05289-0.

DOI:10.1186/s12903-024-05289-0

PMID:39696299

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11658169/

Abstract

OBJECTIVE

A preliminary clinical evaluation of the efficacy, comfort, and adverse reactions of two mandibular advancement devices (MADs) in the treatment of Obstructive Sleep Apnea (OSA).

METHODS

Forty patients with mild-to-severe OSA were recruited and randomly divided into two groups. They were treated with Shark-fin or Silensor MAD, respectively. Treatment efficacy was evaluated by home sleep apnea tests, the snoring scale, Epworth Sleepiness Scale (ESS) and the Pittsburgh Sleep Quality Index (PSQI). A comfort scale questionnaire was applied. Cone beam computed tomography (CBCT), cephalometric radiography, and intraoral scanning were made before and after 3-month treatment to detect temporomandibular joints (TMJ), dental and skeletal changes. All data were assessed as normal distributed and analyzed by t test. The significance level was defined as α = 0.05.

RESULTS

The effective rate, defined as a decrease in Respiratory Event Index (REI) to less than 5 events per hour or a decrease of more than 50%, was 70% in the Shark-fin MAD group and 50% in the Silensor MAD group. REI, lowest oxygen saturation and maximum apnea and hypoventilation time were significantly improved in Shark-fin MAD group (P < 0.01), and the proportion of non-rapid eye movement (REM) sleep stage 3 was higher than before use (P < 0.05), while only REI and lowest oxygen saturation were significantly improved in Silensor MAD group (P < 0.05). The loudness of snoring was significantly decreased after one day using Shark-fin MAD (P < 0.05), and further decreased after one month (P < 0.01). Conversely, Silensor MAD exhibited inferior efficacy in mitigating snoring compared to Shark-fin MAD. Upon wearing the Shark-fin MAD, ESS were significantly improved after one month and three months (P < 0.05), and PSQI improved after three months (P < 0.05). Additionally, the Shark-fin MAD group had a significantly better comfort score compared to the Silensor MAD group (P < 0.05). There was no significant difference in TMJ, dental and skeletal structures in the two groups before and after treatment (P > 0.05).

CONCLUSION

Both two MADs were effective in reducing REI and increasing lowest oxygen saturation on OSA patients, and Shark-fin MAD has better improvement effect and faster onset of action. In addition, Shark-fin MAD was superior to Silensor MAD in improving snoring loudness, daytime sleepiness, sleep quality and wearing comfort. There were no significant dental or skeletal changes, and no alterations in occlusion or temporomandibular joint function in the short term.

TRIAL REGISTRATION

Clinical Trials.gov Registration ID ChiCTR2400086628. Registered 08/07/ 2024-Retrospectively registered, https://register.

CLINICALTRIALS

gov .

摘要

目的

对两种下颌前移装置（MADs）治疗阻塞性睡眠呼吸暂停（OSA）的疗效、舒适度和不良反应进行初步临床评估。

方法

招募40例轻至重度OSA患者，随机分为两组，分别使用鲨鱼鳍型或Silensor MAD进行治疗。通过家庭睡眠呼吸暂停测试、打鼾量表、爱泼华嗜睡量表（ESS）和匹兹堡睡眠质量指数（PSQI）评估治疗效果。应用舒适度量表问卷。在治疗3个月前后进行锥形束计算机断层扫描（CBCT）、头影测量放射摄影和口内扫描，以检测颞下颌关节（TMJ）、牙齿和骨骼变化。所有数据评估为正态分布，采用t检验进行分析。显著性水平定义为α = 0.05。

结果

以呼吸事件指数（REI）降至每小时少于5次事件或下降超过50%为有效率，鲨鱼鳍型MAD组为70%，Silensor MAD组为50%。鲨鱼鳍型MAD组的REI、最低血氧饱和度以及最长呼吸暂停和低通气时间均有显著改善（P < 0.01），非快速眼动（REM）睡眠3期比例高于使用前（P < 0.05），而Silensor MAD组仅REI和最低血氧饱和度有显著改善（P < 0.05）。使用鲨鱼鳍型MAD一天后打鼾响度显著降低（P < 0.05），一个月后进一步降低（P < 0.01）。相反，与鲨鱼鳍型MAD相比，Silensor MAD在减轻打鼾方面疗效较差。佩戴鲨鱼鳍型MAD一个月和三个月后ESS显著改善（P < 0.05），三个月后PSQI改善（P < 0.05）。此外，鲨鱼鳍型MAD组的舒适度评分显著高于Silensor MAD组（P < 0.05）。两组治疗前后TMJ、牙齿和骨骼结构无显著差异（P > 0.05）。